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Recruiting NCT07260253

Remotely-supervised Neuromodulation in PPA

No phase Interventional Primary Progressive Aphasia(PPA) Progressive Aphasia Progressive Aphasia in Alzheimer's Disease Logopenic Progressive Aphasia (LPA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lexical Retrieval Cascade Treatment, Remotely Supervised Transcranial Direct Current Stimulation- Active, Remotely Supervised Transcranial Direct Current Stimulation - Sham.
Who it may be relevant to
Registry conditions: Primary Progressive Aphasia(PPA), Progressive Aphasia, Progressive Aphasia in Alzheimer's Disease, Logopenic Progressive Aphasia (LPA). Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Investigating the Benefits of Remotely-Supervised Neuromodulation In Primary Progressive Aphasia

Overview

The goal of this clinical trial is to learn whether home-based brain stimulation combined with virtual speech-language therapy can improve communication abilities in adults with logopenic variant primary progressive aphasia (lvPPA), a language disorder most often caused by Alzheimer's disease. The main questions the study aims to answer are: * Is combining remotely supervised transcranial direct current stimulation (tDCS) with virtual speech-language therapy feasible and acceptable for people with lvPPA? * Does this combined treatment lead to improvements in communication compared to speech-language therapy with sham (placebo) stimulation? * Do individual brain characteristics help predict who benefits most from this treatment? Researchers will compare participants who receive active tDCS plus virtual speech-language therapy to participants who receive sham (placebo) tDCS plus virtual speech-language therapy to see if active brain stimulation enhances communication outcomes. Participants will: * Complete speech-language therapy sessions delivered by video visit. * Receive either active or sham tDCS that is remotely supervised and completed at home. * Complete language and cognitive testing before and after treatment. * Undergo brain imaging and other assessments to help understand treatment response.

Interventions

  • Behavioral Lexical Retrieval Cascade Treatment
    Participants work on producing spoken and written names of personally-relevant target items. Treatment focuses on the use of strategies that capitalize on spared cognitive-linguistic abilities to support word retrieval. The participant completes two (one hour each) teletherapy sessions per week with a clinician plus 30 minutes of additional independent, computer-based practice exercises 3 times per week.
  • Device Remotely Supervised Transcranial Direct Current Stimulation- Active
    tDCS is a type of non-invasive brain stimulation. 2.0 milliamp (mA) of current will be delivered via electrodes in saline-soaked sponges placed on the left and right sides of the head. The stimulation will last 20 minutes and will occur 5 times weekly, in the participant's home setting, while the participant engages in computer-delivered speech-language training. Sessions are monitored by study personnel.
  • Device Remotely Supervised Transcranial Direct Current Stimulation - Sham
    tDCS is a type of non-invasive brain stimulation. 2.0 milliamp (mA) of current will be delivered via electrodes in saline-soaked sponges placed on the left and right sides of the head. In sham stimulation, current will be delivered for a brief period of time and then turned off. Sham stimulation will last 20 minutes and will occur 5 times weekly, in the participant's home setting, while the participant engages in computer-delivered speech-language training. Sessions are monitored by study person

Primary outcome measures

  • Change in spoken naming [Time frame: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)]
Secondary outcome measures (4)
  • Change on Communication Confidence Rating Scale for Aphasia [Time frame: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)]
  • Change on Aphasia Impact Questionnaire [Time frame: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)]
  • Theoretical Framework of Acceptability Questionnaire [Time frame: one month after onset of treatment]
  • Acceptability and Perception of Change Survey [Time frame: one month after onset of treatment]

Eligibility criteria

Inclusion criteria

  • Meets diagnostic criteria for primary progressive aphasia (PPA)
  • Meets diagnostic criteria for logopenic variant PPA
  • Attains score of 15 or higher on the Mini-Mental State Examination
  • Has adequate hearing and vision (with hearing or vision aids, if needed)
  • Is able to travel to research site and undergo MRI brain scan
  • Has access to high speed internet and basic experience using a computer and the internet
  • Is a fluent speaker of English
  • Has a study partner who can co-enroll in the study, attend pre-treatment training at the research site, and be present for teleconference meetings, as needed

Exclusion criteria

  • Speech and language deficits better accounted for by another neurological disorder
  • Does not meet diagnostic criteria for logopenic variant PPA
  • Scores less than 15 on the Mini-Mental State Examination
  • Does not have a study partner who can co-enroll in the study
  • Has contraindications for tDCS or MRI scan (History of seizures, head injury, craniotomy, skull surgery or fracture; History of severe or frequent migraines; Metallic implant in head or any metal in head; Pacemaker or cardioverter-defibrillator or any other stimulator; Chronic skin problems; Pregnancy)
  • Has a history of stroke, epilepsy, or significant brain injury

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • UCSF Memory and Aging Cener — San Francisco
  • University of Texas — Austin

Publications

  • Dial HR, Hinshelwood HA, Grasso SM, Hubbard HI, Gorno-Tempini ML, Henry ML. Investigating the utility of teletherapy in individuals with primary progressive aphasia. Clin Interv Aging. 2019 Feb 25;14:453-471. doi: 10.2147/CIA.S178878. eCollection 2019. PMID 30880927
  • Henry ML, Hubbard HI, Grasso SM, Dial HR, Beeson PM, Miller BL, Gorno-Tempini ML. Treatment for Word Retrieval in Semantic and Logopenic Variants of Primary Progressive Aphasia: Immediate and Long-Term Outcomes. J Speech Lang Hear Res. 2019 Aug 15;62(8):2723-2749. doi: 10.1044/2018_JSLHR-L-18-0144. Epub 2019 Aug 7. PMID 31390290

Identifiers

NCT: NCT07260253 · RF1AG085565 · RF1AG085565

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗